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Racemic Ketamine as an Alternative to Electroconvulsive Therapy for Unipolar Depression: : A Randomized, Open-Label, Non-Inferiority Trial (KetECT)

Ekstrand, Joakim LU ; Fattah, Christian ; Persson, Marcus LU ; Cheng, Tony LU ; Nordanskog, Pia ; Åkeson, Jonas LU ; Tingström, Anders LU ; Lindström, Mats LU orcid ; Nordenskjöld, Axel and Movahed, Rad Pouya LU (2022) In International Journal of Neuropsychopharmacology 25(5). p.339-349
Abstract
Background
Ketamine has emerged as a fast-acting and powerful antidepressant, but no head to head trial has been performed, Here, ketamine is compared with electroconvulsive therapy (ECT), the most effective therapy for depression.
Methods
Hospitalized patients with unipolar depression were randomized (1:1) to thrice-weekly racemic ketamine (0.5 mg/kg) infusions or ECT in a parallel, open-label, non-inferiority study. The primary outcome was remission (Montgomery Åsberg Depression Rating Scale score ≤10). Secondary outcomes included adverse events (AEs), time to remission, and relapse. Treatment sessions (maximum of 12) were administered until remission or maximal effect was achieved. Remitters were followed for 12 months after... (More)
Background
Ketamine has emerged as a fast-acting and powerful antidepressant, but no head to head trial has been performed, Here, ketamine is compared with electroconvulsive therapy (ECT), the most effective therapy for depression.
Methods
Hospitalized patients with unipolar depression were randomized (1:1) to thrice-weekly racemic ketamine (0.5 mg/kg) infusions or ECT in a parallel, open-label, non-inferiority study. The primary outcome was remission (Montgomery Åsberg Depression Rating Scale score ≤10). Secondary outcomes included adverse events (AEs), time to remission, and relapse. Treatment sessions (maximum of 12) were administered until remission or maximal effect was achieved. Remitters were followed for 12 months after the final treatment session.
Results
In total 186 inpatients were included and received treatment. Among patients receiving ECT, 63% remitted compared with 46% receiving ketamine infusions (P = .026; difference 95% CI 2%, 30%). Both ketamine and ECT required a median of 6 treatment sessions to induce remission. Distinct AEs were associated with each treatment. Serious and long-lasting AEs, including cases of persisting amnesia, were more common with ECT, while treatment-emergent AEs led to more dropouts in the ketamine group. Among remitters, 70% and 63%, with 57 and 61 median days in remission, relapsed within 12 months in the ketamine and ECT groups, respectively (P = .52).
Conclusion
Remission and cumulative symptom reduction following multiple racemic ketamine infusions in severely ill patients (age 18–85 years) in an authentic clinical setting suggest that ketamine, despite being inferior to ECT, can be a safe and valuable tool in treating unipolar depression. (Less)
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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Electroconvulsive therapy, ketamine infusion, major depressive disorder, psychotic depression, racemic ketamine
in
International Journal of Neuropsychopharmacology
volume
25
issue
5
pages
339 - 349
publisher
Cambridge University Press
external identifiers
  • pmid:35020871
  • scopus:85125054980
ISSN
1469-5111
DOI
10.1093/ijnp/pyab088
language
English
LU publication?
yes
id
5106fb3d-8fdc-44eb-9b0b-6567ca84d9e9
date added to LUP
2022-01-19 08:59:15
date last changed
2022-07-26 04:31:49
@article{5106fb3d-8fdc-44eb-9b0b-6567ca84d9e9,
  abstract     = {{Background<br/>Ketamine has emerged as a fast-acting and powerful antidepressant, but no head to head trial has been performed, Here, ketamine is compared with electroconvulsive therapy (ECT), the most effective therapy for depression.<br/>Methods<br/>Hospitalized patients with unipolar depression were randomized (1:1) to thrice-weekly racemic ketamine (0.5 mg/kg) infusions or ECT in a parallel, open-label, non-inferiority study. The primary outcome was remission (Montgomery Åsberg Depression Rating Scale score ≤10). Secondary outcomes included adverse events (AEs), time to remission, and relapse. Treatment sessions (maximum of 12) were administered until remission or maximal effect was achieved. Remitters were followed for 12 months after the final treatment session.<br/>Results<br/>In total 186 inpatients were included and received treatment. Among patients receiving ECT, 63% remitted compared with 46% receiving ketamine infusions (P = .026; difference 95% CI 2%, 30%). Both ketamine and ECT required a median of 6 treatment sessions to induce remission. Distinct AEs were associated with each treatment. Serious and long-lasting AEs, including cases of persisting amnesia, were more common with ECT, while treatment-emergent AEs led to more dropouts in the ketamine group. Among remitters, 70% and 63%, with 57 and 61 median days in remission, relapsed within 12 months in the ketamine and ECT groups, respectively (P = .52).<br/>Conclusion<br/>Remission and cumulative symptom reduction following multiple racemic ketamine infusions in severely ill patients (age 18–85 years) in an authentic clinical setting suggest that ketamine, despite being inferior to ECT, can be a safe and valuable tool in treating unipolar depression.}},
  author       = {{Ekstrand, Joakim and Fattah, Christian and Persson, Marcus and Cheng, Tony and Nordanskog, Pia and Åkeson, Jonas and Tingström, Anders and Lindström, Mats and Nordenskjöld, Axel and Movahed, Rad Pouya}},
  issn         = {{1469-5111}},
  keywords     = {{Electroconvulsive therapy, ketamine infusion, major depressive disorder, psychotic depression, racemic ketamine}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{339--349}},
  publisher    = {{Cambridge University Press}},
  series       = {{International Journal of Neuropsychopharmacology}},
  title        = {{Racemic Ketamine as an Alternative to Electroconvulsive Therapy for Unipolar Depression: : A Randomized, Open-Label, Non-Inferiority Trial (KetECT)}},
  url          = {{http://dx.doi.org/10.1093/ijnp/pyab088}},
  doi          = {{10.1093/ijnp/pyab088}},
  volume       = {{25}},
  year         = {{2022}},
}